Staff Supplier & Manufacturing Quality Engineer

Company	Butterfly Network
Location	New York, NY, USA, Burlington, MA, USA
Salary	$125000 – $145000
Type	Full-Time
Degrees	Bachelor’s
Experience Level	Senior

BS degree in Engineering or Technical Field or equivalent experience
Min 5 years of Medical Device Supplier Quality experience
Ability to work in a geographically diverse business environment
Ability to operate in an electronic Quality Management System
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to work independently and manage the electronic Supplier Quality Management System in Trackwise Digital QMS
Experience with root cause identification and problem solving
Strong organizational and follow-up skills, as well as attention to detail
Excellent interpersonal skills with the ability to mentor
Ability to work in a timeline driven environment
Excellent communication skills, both written and oral
Working Knowledge of current Regulations and Guidelines such as: GMP, ISO 13485; ISO 14971, FDA 21 CFR Part 820; (EU) 2017/745 (MDR)
Ability to travel internationally <10% for onsite critical supplier audits, remediation of quality-related issues, and/or supplier relationship management
Ability to obtain a Visa for travel to China

Reviews and approves all supplied product drawings and component quality plans
Manages the development of supplied product inspection procedures and first article requirements
Assesses supplier capabilities through quality system audits
Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions
Participates in Quality Review Board and Change Control Review Board meetings
Monitors supplier performance
Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies
Works with Manufacturing engineering to assess and address product issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Process optimization and/or improvement
Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, Control Plans, and IQ/OQ/PQ documentation
Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers/vendors
Contributes to the development, maintenance, and improvement of Butterfly Network’s supplier quality program, system, and procedures
Performs other related duties and responsibilities, as assigned